Company: Philips Medical Systems, Inc.
Date of Enforcement Report 12/14/2016
Class lI:
PRODUCT
Ingenuity Core 128 728323 Computed Tomography X-ray systems
Recall Number Z-0696-2017
REASON
Software error due to the filament on timer.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Cleveland, OH on 11/12/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
509
DISTRIBUTION
Nationwide and Internationally
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IEC 62304 and other emerging standards for Medical Device and HealthIT Software
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This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.
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